Neurophysiological and Behavioral Effects of Combining Transcranial Direct Current Stimulation (tDCS) and Modified-Constraint Induced Movement Therapy (mCIMT)
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Stroke, Hemiparesis of the Upper Limb Following Stroke, Stroke Rehabilitatiom
In brief
This clinical trial aims to evaluate the effect of different types of tDCS modulation with mCIMT in improving affected upper-limb motor function for stroke patients. The main question it seeks to answer: Which type of tDCS (bi-hemispheric, anodal, or cathodal) combined with the mCIMT program leads to greater improvement in affected upper-limb function in patients with stroke? Researchers will compare these three types of tDCS to a sham tDCS. To see which kind of tDCS protocol combined with the mCIMT program will be more effective in improving affected upper-limb function for stroke patients. Participants will: 1. Participants will receive 12 sessions of mCIMT combined with tDCS or mCIMT alone. 2. Visit the clinic three times a week for four weeks. 3. Participants will do fMRI and TMS before and after the program and three times of assessment before and after two weeks after the program.
Key facts
- Study ID
- NCT06786000
- Run by
- King Saud University
- People needed
- 300
- Starts
- 2023-04-11
- Expected to finish
- 2025-04-11
- Last updated by the study team
- 2025-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult participants clinically diagnosed and confirmed by imaging of ischemic or hemorrhagic cerebrovascular accident (Dahl et al., 2008; Jin et al., 2019).
- Participant's age older than 18 years (Baltar et al., 2020).
- Stroke onset more than 3 months with unilateral motor deficits (Lin et al., 2010).
- Adequate cognitive function is required to follow instructions. The Arabic version of the Mini Mental State Examination (MMSE) should be ≥24 (Kim, 2021).
- 10° of active extension to the metacarpophalangeal and interphalangeal joints and 20° at wrist will be assessed by manual goniometer (Dahl et al., 2008).
- Fugl-Meyer assessment (FMA) scores between 19 and 58, indicating moderate to mild impairments.
- Not participating in other clinical, or research studies at the same time.
You may not qualify if…
- Severe muscle spasticity at the affected limb at all joints (the Modified Ashworth Scale scores > 3) (Baltar et al., 2020).
- Contraindications to NIBS (Bornheim et al., 2019).
- Unilateral neglect (Dahl et al., 2008)
- Other neurologic or orthopedic conditions that may affect hand function.
- Unstable medical conditions.
Where it is running
- King Saud University Medical City — Riyadh, Riyadh Region, Saudi Arabia (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.